Navigation Links
Johnson & Johnson Violated FDA Order to Halt Sales of Transvaginal Mesh
Date:6/27/2012

(PRWEB) June 27, 2012

In complete disregard of an order by the U.S. Food and Drug Administration (FDA) to stop marketing the Gynecare Prolift vaginal mesh implant, Johnson and Johnson (J&J) continued to sell the product for nine additional months. According to court records, in a letter dated August 24, 2007, the FDA advised J&J to halt the sales of the Gynecare Prolift until such time the agency determined whether the device was the “substantially equivalent” to other mesh products on the market. The letter clearly stated, “You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food Drug and Cosmetic Act.” Despite this warning, J&J continued to sell the mesh product until the FDA cleared the device in May 2008 after months of negotiations with J&J.

J&J initially began selling the Prolift in 2005. It failed to apply for application and approval from the FDA because it unilaterally determined its product was substantially similar to the Gynemesh product already approved by the FDA, according to Matthew Johnson, J&J spokesman. The FDA disagreed and required a new application be submitted. The company’s failure to initially heed FDA orders could prove costly. Currently there are more than 1,400 lawsuits pending against J&J by women injured by the mesh device, which has caused scarring, perforation of other organs, nerve damage and intense pain. “Women suffering injuries from the defective device should be outraged at both J&J and the FDA for their respective failures in ensuring that safe products are on the market,” says attorney Holly Ennis from Ennis & Ennis, P.A., a firm representing women nationwide injured by transvaginal mesh devices.

On June 5, 2012, J&J announced it would stop selling four vaginal mesh implants including the Prolift. The company is quick to note that this is not a recall but a “planned discontinuation” of the mesh products over the next several months. However, the FDA has concerns over the safety of these devices due to the number of complications relating to the devices, as indicated by the high number of adverse events filed with the FDA. Such problems include infection, abscess and organ perforation, most of which required additional surgery.

Lawsuits are currently pending in state court in Atlantic City, New Jersey and in Federal Court in the U.S. District Court, Southern District of West Virginia (Charleston).

For women who have suffered as a result of a vaginal mesh implant, it is not too late to file a claim. Contact Ennis & Ennis, P.A. for a FREE nationwide confidential consultation by calling toll free 1-800-856-6405 or by completing an online case evaluation form at http://www.ennislaw.com.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies and medical device makers.

Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

Ennis & Ennis, P.A. is also investigating cases involving Accutane, Actos, Avandia, Fosamax, Pradaxa, Plavix, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Wright Conserve Hip, Wright Profemur Hip, all Metal-on-Metal Hips, Tekturna, Reglan, Medtronic Infuse Bone Graft, Yaz, Yasmin and Ocella Birth Control Pills.

Remember the law limits the time in which a claim can be filed, so don't wait. Call today toll free 1-800-856-6405 or visit http://www.ennislaw.com.

Read the full story at http://www.prweb.com/releases/2012/6/prweb9644796.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. Research shows efficacy of treatment model developed at Women & Infants
2. Soy-based S-equol supplement reduces hot flash frequency, muscle & joint pain in US women
3. Vendors in Nevada, Michigan, & Illinois to be Featured on the PartyPOP.com Online Network
4. Beef & Pork Wholesaling in the US Industry Market Research Report Now Available from IBISWorld
5. The Tennessee Car Accident Lawyers at Michael D. Ponce & Associates Alert Public of CDC Survey Revealing Majority of High School Seniors Admitting to Texting Behind Wheel
6. Alex Galindo, Attorney and Partner at Curd, Galindo & Smith, LLP, Court Wins Against the County of Riverside's Motion to Dismiss Medical Malpractice Case
7. Play & Park Structures Included in New Play for All Abilities Playground
8. Gum Disease, HPV May Play Role in Head & Neck Cancers
9. New Treatments Emerging from Immune and Inflammatory Disease R&D Pipelines
10. Version 2.0 of Award-Winning Proloquo2Go App for iPhone, iPad & iPod touch Speeds Up Communication, Adds New Voices and Customization Options
11. Ear, Nose & Throat Journal publishes research on breakthrough treatment for tonsil stones
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2017)... ... May 26, 2017 , ... Water damage to the flooring of several ... had left education officials with a number of critical issues to address before students ... to be accomplished with little or no disruption to class schedules. Second, the project ...
(Date:5/24/2017)... ... May 24, 2017 , ... In modern research, success depends ... instruments for research and understanding the basic principles that were designed to drive ... innovations in stereo microscopy for brightfield and fluorescence typically used in laboratories working ...
(Date:5/24/2017)... ... 24, 2017 , ... Altec Products, Inc., a leader in enterprise ... one-day technology conference in San Diego, CA. , At nVerge 2017, Altec will ... utilize and enhance their Sage ERP solutions by providing improved visibility and control to ...
(Date:5/24/2017)... ... May 24, 2017 , ... Drs. ... NY, who have now spent 10 years as clinical instructors for the reputable ... College of Dentistry. Through the program, private practitioners receive cutting-edge clinical training and ...
(Date:5/24/2017)... ... , ... Patients who want to receive cosmetic dentistry procedures such as Invisalign® ... for a consultation, with or without a referral. Dr. Bedich enjoys improving the appearance ... , Dr. Bedich offers a variety of cosmetic dentistry services at his practice that ...
Breaking Medicine News(10 mins):
(Date:5/10/2017)... MARLBOROUGH, Mass., May 10, 2017 Hologic, Inc. ... financial results for the fiscal second quarter ended April ... (EPS) of $1.84 increased 666.7% compared to the prior ... business resulted in a significant gain, while non-GAAP diluted ... increased 3.2%, or 3.8% in constant currency terms.  Excluding ...
(Date:5/10/2017)... Md. , May 10, 2017 CSSi, ... solutions for the clinical research industry, is proud to ... www.CSSiEnroll.com . The new website features both enriched content ... user experience and enhances the company,s already well-established position ... industry. "After many months of hard ...
(Date:5/9/2017)... 9, 2017  Semler Scientific, Inc. (OTCQB: SMLR), ... to improve the clinical effectiveness and efficiency of ... first quarter ended March 31, 2017. ... customers to identify when preventive care options are ... like heart attacks or strokes occur," said ...
Breaking Medicine Technology: